Aesculap Pneumatic Kerrison
510(k) K062413
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062413 | Date21 Nov 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HAD
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4845
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Aesculap Pneumatic Kerrison is a Powered, Pneumatic Rongeur (OpenFDA classification: HAD), designed for precise bone resection in neurosurgical procedures. It operates using compressed air to deliver controlled cutting force, enabling efficient removal of bone fragments while minimizing trauma to surrounding tissues. Its design aligns with traditional Kerrison rongeurs but incorporates pneumatic actuation for enhanced ergonomics and reduced operator fatigue. This device is classified under FDA regulation number 882.4845 and falls within Device Class II for neurological applications.
The device is supplied as a reusable surgical instrument, intended for use in sterile operating environments under direct surgeon supervision. It is powered by compressed air and requires compatible pneumatic systems for operation, with no inherent MRI compatibility restrictions. Available in multiple patterns and configurations (including detachable and non-detachable styles), the Kerrison is stored in a clean, dry setting and maintained per manufacturer guidelines. Its FDA 510(k) clearance (K062413) reflects substantial equivalence to prior-generation pneumatic bone resection tools, with no additional regulatory markings stated.
Other devices from Aesculap, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Aesculap Pneumatic Kerrison used for?
The Aesculap Pneumatic Kerrison is designed specifically for neurosurgical procedures to perform precise bone resection. Its pneumatic actuation delivers controlled cutting force, allowing surgeons to efficiently remove bone fragments while minimizing damage to surrounding tissues. This makes it ideal for delicate operations where accuracy and reduced trauma are critical.
How is the Aesculap Pneumatic Kerrison powered and supplied?
This device operates using compressed air, requiring compatible pneumatic systems for activation. It is supplied as a reusable surgical instrument, intended for use in sterile operating environments under direct surgeon supervision. The pneumatic design enhances ergonomics and reduces operator fatigue compared to manual tools.
Is the Aesculap Pneumatic Kerrison single-use or reusable?
The Aesculap Pneumatic Kerrison is a reusable surgical instrument. It must be maintained and stored in a clean, dry setting according to the manufacturer’s guidelines to ensure proper functionality and sterility for repeated use in sterile environments.
What configurations or patterns are available for the Aesculap Pneumatic Kerrison?
The device is available in multiple patterns and configurations, including both detachable and non-detachable styles. These variations allow surgeons to select the most suitable design for their specific neurosurgical procedure, ensuring versatility in bone resection applications.
Does the Aesculap Pneumatic Kerrison have any MRI compatibility restrictions?
The Aesculap Pneumatic Kerrison does not have inherent MRI compatibility restrictions, though its use in an MRI environment should still follow standard safety protocols. Since it relies on pneumatic power, compatibility depends on the operating room’s infrastructure rather than the device itself.